Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 84 of 141 for:    MPL

A Safety and Efficacy Study of Eltrombopag in Subjects With AML

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01890746
Recruitment Status : Completed
First Posted : July 2, 2013
Results First Posted : June 14, 2016
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Leukaemia, Acute
Interventions Drug: Daunorubicin
Drug: Cytarabine
Drug: Eltrombopag
Drug: Placebo
Enrollment 148
Recruitment Details Participants (Par.) diagnosed with Acute Myelogenous Leukemia (AML) of any subtype (except acute promyelocytic [M3] or acute megakaryocytic leukaemia [M7]) were eligible for the study.
Pre-assignment Details Sufficient number of participants were screened and 148 participants were randomized and entered in to the study. Participants were stratified by antecedent malignant hematologic disorder (yes versus no) and age (18-60 years versus >60 years), before they were randomized to receive study treatments.
Arm/Group Title Eltrombopag (ELT) QD Placebo QD
Hide Arm/Group Description Par. received (rec) first line induction (IDN) chemotherapy (CTY) consisting of daunorubicin (DAU) bolus intravenous (IV) infusion (INF) on Days (D) 1-3 at a dose of 90 milligrams (mg)/square meter (m^2) for Par. 18-60 year (yr) or 60 mg/m^2 for >60 yr plus cytarabine (CB) 100 mg/m^2 continuous IV INF on D1-7. Par. rec ELT as 200 mg (100 mg for East-Asian Heritage [EAH]) once daily (QD) oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If platelet (PT) count was not >100 Giga (Gi)/Liter (L) after 7D the dose was increased to 300 mg (150 mg for EAH) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42D from the start of the CTY IDN cycle. Par. not aplastic after first cycle of IDN CTY rec re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus CB 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration. Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Period Title: Overall Study
Started 74 74
Completed 0 0
Not Completed 74 74
Reason Not Completed
Adverse Event             1             0
Physician Decision             2             2
Withdrawal by Subject             4             8
Death             23             14
Ongoing             44             50
Arm/Group Title Eltrombopag QD Placebo QD Total
Hide Arm/Group Description Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration. Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days. Total of all reporting groups
Overall Number of Baseline Participants 74 74 148
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 74 participants 148 participants
56.7  (12.25) 56.6  (11.58) 56.7  (11.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 148 participants
Female
38
  51.4%
31
  41.9%
69
  46.6%
Male
36
  48.6%
43
  58.1%
79
  53.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 148 participants
African American/African Heritage 1 2 3
Asian - Central/South Asian Heritage 0 1 1
Asian - East Asian Heritage 26 17 43
Asian - South East Asian Heritage 0 1 1
White - Arabic/North African Heritage 5 3 8
White - White/Caucasian/European Heritage 42 50 92
1.Primary Outcome
Title Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE) as a Measure of Safety and Tolerability.
Hide Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.
Time Frame From the time the first dose of study treatment was administered until 30 days following discontinuation of investigational product regardless of initiation of a new cancer therapy or transfer to hospice
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all subjects who received at least one dose of investigational product.
Arm/Group Title Eltrombopag QD Placebo QD
Hide Arm/Group Description:
Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Overall Number of Participants Analyzed 74 71
Measure Type: Number
Unit of Measure: Participants
Any AE 72 66
Any SAE 24 14
2.Primary Outcome
Title Change From Baseline in the Left Ventricular Ejection Fraction (LVEF).
Hide Description LVEF is a measurement of the percentage of blood leaving heart each time it contracts. LVEF was assessed by an echocardiogram (ECHO) or Multiple Gated Acquisition scan (MUGA). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the Day 42 value minus the Baseline value.
Time Frame Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Population who provided Baseline and Day 42 LVEF measurements.
Arm/Group Title Eltrombopag QD Placebo QD
Hide Arm/Group Description:
Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Overall Number of Participants Analyzed 57 62
Mean (Standard Deviation)
Unit of Measure: LVEF percent
-2.5  (7.81) -4.3  (8.54)
3.Primary Outcome
Title Number of Participants With Worst-case Grade Changes From Baseline in the Hematology Parameters
Hide Description The number of participants with a maximum post-baseline grade increase of Grade 3 (G3) or Grade 4 (G4) from their baseline grade are presented. Hematology parameters included only lab tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Time Frame Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Eltrombopag QD Placebo QD
Hide Arm/Group Description:
Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Overall Number of Participants Analyzed 74 71
Measure Type: Number
Unit of Measure: Participants
Hemoglobin Low, G3 53 46
Leukocytes, G3 5 0
Leukocytes, G4 65 64
Lymphocytes Low, G3 31 26
Lymphocytes Low, G4 35 38
Neutrophils, G4 44 39
Platelets, G3 1 0
Platelets, G4 63 56
4.Primary Outcome
Title Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters
Hide Description The number of participants with a maximum post-baseline grade increase of Grade 3 or Grade 4 from their baseline grade are presented. Clinical Clinical Chemistry parameters included only lab tests that are gradable by CTCAE v4.0.
Time Frame Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Eltrombopag QD Placebo QD
Hide Arm/Group Description:
Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Overall Number of Participants Analyzed 74 71
Measure Type: Number
Unit of Measure: Participants
Alanine Aminotransferase, G3 1 5
Albumin, G3 6 4
Aspartate Aminotransferase, G3 0 1
Bilirubin, G3 1 4
Bilirubin, G4 0 1
Calcium Low, G3 0 1
Creatinine, G3 0 1
Creatinine, G4 1 0
Glucose High, G3 6 3
Glucose High, G4 0 1
Magnesium Low, G3 0 1
Magnesium High, G3 3 0
Phosphate, G3 10 19
Phosphate, G4 1 0
Potassium Low, G3 8 10
Potassium Low, G4 0 2
Potassium High, G3 4 0
Potassium High, G4 1 1
Sodium Low, G3 3 4
Urate, G4 3 0
5.Primary Outcome
Title Number of Participants With Liver Events.
Hide Description The number of participants with liver enzyme (ALT, AST, ALP, Total bilirubin) abnormalities while receiving study treatment in each arm are presented.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Eltrombopag QD Placebo QD
Hide Arm/Group Description:
Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Overall Number of Participants Analyzed 74 71
Measure Type: Number
Unit of Measure: Participants
2 6
6.Primary Outcome
Title Number of Participants With Worst-case Changes From Baseline in Electrocardiogram (ECG) Values
Hide Description The number of participants with worst case post-baseline changes (normal, abnormal - not clinically significant [NCS], abnormal - clinically significant [NS]) in ECG QT prolonged values are presented. The protocol does not define the criteria for normal, abnormal-NCS and abnormal CS ECG. The outcome was based solely on the investigator interpretation of ECG tracings.
Time Frame Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Eltrombopag QD Placebo QD
Hide Arm/Group Description:
Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Overall Number of Participants Analyzed 74 71
Measure Type: Number
Unit of Measure: Participants
Normal 34 33
Abnormal - NCS 23 29
Abnormal - CS 2 1
7.Primary Outcome
Title Number of Participants With Worst-case Changes From Baseline in the Eastern Cooperative Oncology Group (ECOG) Performance Status
Hide Description The number of participants with worst case post-baseline changes (improved, no change, deteriorated) are presented.
Time Frame Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Population who provided Baseline and post-Baseline assessments.
Arm/Group Title Eltrombopag QD Placebo QD
Hide Arm/Group Description:
Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Overall Number of Participants Analyzed 73 71
Measure Type: Number
Unit of Measure: Participants
Deteriorated 36 36
Improved 0 1
No Change 37 34
8.Primary Outcome
Title Worst-case Change From Baseline in Pulse Rate Values
Hide Description The worst-case post Baseline high and low changes in pulse rate values from Baseline are presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Post Baseline is defined as the highest and lowest non-missing post Baseline value respectively. Change from Baseline was calculated as the post Baseline value minus the Baseline value.
Time Frame Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the indicated time points were analyzed (represented by n=X, X in the category titles)
Arm/Group Title Eltrombopag QD Placebo QD
Hide Arm/Group Description:
Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Overall Number of Participants Analyzed 74 71
Mean (Standard Deviation)
Unit of Measure: Beats/minute
High, n=66, 67 18.48  (20.616) 17.73  (15.112)
Low, n=61, 55 -10.36  (14.039) -11.24  (12.123)
9.Primary Outcome
Title Worst-case Post Baseline Change in Blood Pressure Values From Baseline
Hide Description The worst-case post Baseline high changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) values from Baseline are presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the visit value minus the Baseline value.
Time Frame Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Eltrombopag QD Placebo QD
Hide Arm/Group Description:
Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Overall Number of Participants Analyzed 74 71
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
SBP 14.59  (17.936) 14.34  (14.626)
DBP 9.38  (12.000) 12.61  (10.947)
10.Primary Outcome
Title Worst-case Post Baseline Change in Temperature Values From Baseline
Hide Description The worst-case post Baseline high and low changes in temperature values from Baseline are presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Post Baseline was defined as the highest and lowest non-missing post Baseline value respectively. Change from Baseline was calculated as the post Baseline value minus the Baseline value.
Time Frame Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the indicated time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title Eltrombopag QD Placebo QD
Hide Arm/Group Description:
Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
Overall Number of Participants Analyzed 74 71
Mean (Standard Deviation)
Unit of Measure: Degrees Celsius
High, n=70, 69 0.62  (0.941) 0.77  (0.879)
Low, n=47, 43 -0.44  (0.628) -0.63  (0.592)
Time Frame On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the time the first dose of study treatment was administered until 30 days following discontinuation of investigational product.
Adverse Event Reporting Description On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
 
Arm/Group Title Eltrombopag QD Placebo QD
Hide Arm/Group Description Par. received IDN CTY of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg QD oral dose started on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par.who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration. Participants received first line induction chemotherapy consisted of daunorubicin bolus IV infusion on Days 1 – 3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV infusion on Days 1 – 7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose started on Day 4 of initial induction chemotherapy at least 20 hours after end of Day 3 daunorubicin infusion up to a maximum duration of 42 days.
All-Cause Mortality
Eltrombopag QD Placebo QD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eltrombopag QD Placebo QD
Affected / at Risk (%) Affected / at Risk (%)
Total   24/74 (32.43%)   14/71 (19.72%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  1/74 (1.35%)  0/71 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  2/74 (2.70%)  0/71 (0.00%) 
Cardiac failure  1  1/74 (1.35%)  1/71 (1.41%) 
Left ventricular dysfunction  1  1/74 (1.35%)  0/71 (0.00%) 
Myocardial infarction  1  1/74 (1.35%)  0/71 (0.00%) 
Cardiac failure congestive  1  0/74 (0.00%)  1/71 (1.41%) 
Cardiomyopathy  1  0/74 (0.00%)  1/71 (1.41%) 
Congenital, familial and genetic disorders     
Hydrocele  1  1/74 (1.35%)  0/71 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/74 (1.35%)  0/71 (0.00%) 
Constipation  1  0/74 (0.00%)  1/71 (1.41%) 
Neutropenic colitis  1  0/74 (0.00%)  1/71 (1.41%) 
General disorders     
Pyrexia  1  1/74 (1.35%)  1/71 (1.41%) 
Generalised oedema  1  0/74 (0.00%)  1/71 (1.41%) 
Sudden death  1  0/74 (0.00%)  1/71 (1.41%) 
Infections and infestations     
Septic shock  1  2/74 (2.70%)  2/71 (2.82%) 
Appendicitis  1  1/74 (1.35%)  0/71 (0.00%) 
Bronchitis  1  1/74 (1.35%)  0/71 (0.00%) 
Klebsiella sepsis  1  1/74 (1.35%)  0/71 (0.00%) 
Sepsis  1  1/74 (1.35%)  2/71 (2.82%) 
Systemic candida  1  1/74 (1.35%)  0/71 (0.00%) 
Acinetobacter bacteraemia  1  0/74 (0.00%)  1/71 (1.41%) 
Device related infection  1  0/74 (0.00%)  1/71 (1.41%) 
Neutropenic sepsis  1  0/74 (0.00%)  1/71 (1.41%) 
Perirectal abscess  1  0/74 (0.00%)  1/71 (1.41%) 
Pneumonia  1  0/74 (0.00%)  1/71 (1.41%) 
Investigations     
Blood bilirubin increased  1  1/74 (1.35%)  0/71 (0.00%) 
Alanine aminotransferase increased  1  0/74 (0.00%)  1/71 (1.41%) 
Ejection fraction decreased  1  0/74 (0.00%)  2/71 (2.82%) 
Metabolism and nutrition disorders     
Pseudohyperkalaemia  1  1/74 (1.35%)  0/71 (0.00%) 
Hypernatraemia  1  0/74 (0.00%)  1/71 (1.41%) 
Nervous system disorders     
Haemorrhage intracranial  1  2/74 (2.70%)  0/71 (0.00%) 
Cerebral haemorrhage  1  1/74 (1.35%)  0/71 (0.00%) 
Cerebrovascular accident  1  1/74 (1.35%)  0/71 (0.00%) 
Cognitive disorder  1  1/74 (1.35%)  0/71 (0.00%) 
Renal and urinary disorders     
Acute kidney injuryl  1  3/74 (4.05%)  1/71 (1.41%) 
Renal failure  1  1/74 (1.35%)  0/71 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary alveolar haemorrhage  1  1/74 (1.35%)  0/71 (0.00%) 
Pulmonary embolism  1  1/74 (1.35%)  0/71 (0.00%) 
Pulmonary haemorrhage  1  1/74 (1.35%)  0/71 (0.00%) 
Respiratory failure  1  1/74 (1.35%)  0/71 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Eltrombopag QD Placebo QD
Affected / at Risk (%) Affected / at Risk (%)
Total   72/74 (97.30%)   66/71 (92.96%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  39/74 (52.70%)  42/71 (59.15%) 
Anaemia  1  7/74 (9.46%)  7/71 (9.86%) 
Neutropenia  1  5/74 (6.76%)  5/71 (7.04%) 
Thrombocytopenia  1  4/74 (5.41%)  4/71 (5.63%) 
Thrombocytosis  1  5/74 (6.76%)  0/71 (0.00%) 
Cardiac disorders     
Sinus tachycardia  1  1/74 (1.35%)  4/71 (5.63%) 
Tachycardia  1  3/74 (4.05%)  2/71 (2.82%) 
Bradycardia  1  3/74 (4.05%)  0/71 (0.00%) 
Palpitations  1  2/74 (2.70%)  1/71 (1.41%) 
Eye disorders     
Dry eye  1  3/74 (4.05%)  3/71 (4.23%) 
Eye swelling  1  2/74 (2.70%)  0/71 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  42/74 (56.76%)  42/71 (59.15%) 
Nausea  1  37/74 (50.00%)  46/71 (64.79%) 
Vomiting  1  27/74 (36.49%)  27/71 (38.03%) 
Constipation  1  28/74 (37.84%)  21/71 (29.58%) 
Stomatitis  1  19/74 (25.68%)  18/71 (25.35%) 
Abdominal pain  1  18/74 (24.32%)  17/71 (23.94%) 
Dyspepsia  1  10/74 (13.51%)  9/71 (12.68%) 
Haemorrhoids  1  10/74 (13.51%)  9/71 (12.68%) 
Abdominal pain upper  1  3/74 (4.05%)  11/71 (15.49%) 
Proctalgia  1  4/74 (5.41%)  10/71 (14.08%) 
Gingival bleeding  1  6/74 (8.11%)  4/71 (5.63%) 
Abdominal distension  1  3/74 (4.05%)  6/71 (8.45%) 
Dry mouth  1  7/74 (9.46%)  2/71 (2.82%) 
Gingival swelling  1  3/74 (4.05%)  5/71 (7.04%) 
Abdominal discomfort  1  2/74 (2.70%)  5/71 (7.04%) 
Gingival pain  1  4/74 (5.41%)  3/71 (4.23%) 
Gastrooesophageal reflux disease  1  2/74 (2.70%)  4/71 (5.63%) 
Mouth ulceration  1  2/74 (2.70%)  4/71 (5.63%) 
Colitis  1  2/74 (2.70%)  3/71 (4.23%) 
Lip dry  1  4/74 (5.41%)  1/71 (1.41%) 
Mouth haemorrhage  1  5/74 (6.76%)  0/71 (0.00%) 
Oral pain  1  3/74 (4.05%)  2/71 (2.82%) 
Toothache  1  2/74 (2.70%)  3/71 (4.23%) 
Abdominal pain lower  1  0/74 (0.00%)  4/71 (5.63%) 
Anal fissure  1  3/74 (4.05%)  1/71 (1.41%) 
Rectal haemorrhage  1  3/74 (4.05%)  1/71 (1.41%) 
Dysphagia  1  0/74 (0.00%)  2/71 (2.82%) 
Lower gastrointestinal haemorrhage  1  2/74 (2.70%)  0/71 (0.00%) 
Mouth swelling  1  2/74 (2.70%)  0/71 (0.00%) 
Neutropenic colitis  1  2/74 (2.70%)  0/71 (0.00%) 
Oesophageal pain  1  0/74 (0.00%)  2/71 (2.82%) 
General disorders     
Pyrexia  1  25/74 (33.78%)  17/71 (23.94%) 
Chills  1  21/74 (28.38%)  14/71 (19.72%) 
Asthenia  1  13/74 (17.57%)  12/71 (16.90%) 
Oedema peripheral  1  11/74 (14.86%)  13/71 (18.31%) 
Fatigue  1  10/74 (13.51%)  11/71 (15.49%) 
Mucosal inflammation  1  9/74 (12.16%)  9/71 (12.68%) 
Oedema  1  6/74 (8.11%)  7/71 (9.86%) 
Pain  1  3/74 (4.05%)  6/71 (8.45%) 
Chest pain  1  3/74 (4.05%)  5/71 (7.04%) 
Catheter site haemorrhage  1  4/74 (5.41%)  1/71 (1.41%) 
Catheter site erythema  1  0/74 (0.00%)  3/71 (4.23%) 
Catheter site haematoma  1  3/74 (4.05%)  0/71 (0.00%) 
Mucosal haemorrhage  1  2/74 (2.70%)  1/71 (1.41%) 
Peripheral swelling  1  1/74 (1.35%)  2/71 (2.82%) 
Catheter site bruise  1  0/74 (0.00%)  2/71 (2.82%) 
Chest discomfort  1  2/74 (2.70%)  0/71 (0.00%) 
Face oedema  1  0/74 (0.00%)  2/71 (2.82%) 
Feeling hot  1  0/74 (0.00%)  2/71 (2.82%) 
Malaise  1  0/74 (0.00%)  2/71 (2.82%) 
Non-cardiac chest pain  1  2/74 (2.70%)  0/71 (0.00%) 
Hepatobiliary disorders     
Hepatic function abnormal  1  2/74 (2.70%)  1/71 (1.41%) 
Immune system disorders     
Drug hypersensitivity  1  2/74 (2.70%)  1/71 (1.41%) 
Infections and infestations     
Device related infection  1  5/74 (6.76%)  7/71 (9.86%) 
Pneumonia  1  8/74 (10.81%)  3/71 (4.23%) 
Oral candidiasis  1  1/74 (1.35%)  6/71 (8.45%) 
Sepsis  1  4/74 (5.41%)  3/71 (4.23%) 
Cellulitis  1  0/74 (0.00%)  6/71 (8.45%) 
Fungal infection  1  3/74 (4.05%)  3/71 (4.23%) 
Bacteraemia  1  4/74 (5.41%)  1/71 (1.41%) 
Enterococcal infection  1  2/74 (2.70%)  2/71 (2.82%) 
Neutropenic sepsis  1  2/74 (2.70%)  2/71 (2.82%) 
Oral herpes  1  1/74 (1.35%)  3/71 (4.23%) 
Bacterial infection  1  2/74 (2.70%)  1/71 (1.41%) 
Catheter site infection  1  2/74 (2.70%)  1/71 (1.41%) 
Diverticulitis  1  2/74 (2.70%)  1/71 (1.41%) 
Sinusitis  2  2/74 (2.70%)  1/71 (1.41%) 
Tinea pedis  1  3/74 (4.05%)  0/71 (0.00%) 
Urinary tract infection  1  2/74 (2.70%)  1/71 (1.41%) 
Abscess limb  1  0/74 (0.00%)  2/71 (2.82%) 
Anal abscess  1  2/74 (2.70%)  0/71 (0.00%) 
Candida infection  1  0/74 (0.00%)  2/71 (2.82%) 
Clostridium difficile infection  1  0/74 (0.00%)  2/71 (2.82%) 
Conjunctivitis  1  2/74 (2.70%)  0/71 (0.00%) 
Folliculitis  1  2/74 (2.70%)  0/71 (0.00%) 
Herpes simplex  1  2/74 (2.70%)  0/71 (0.00%) 
Herpes virus infection  1  2/74 (2.70%)  0/71 (0.00%) 
Infection  1  2/74 (2.70%)  0/71 (0.00%) 
Septic shock  1  2/74 (2.70%)  0/71 (0.00%) 
Staphylococcal infection  1  0/74 (0.00%)  2/71 (2.82%) 
Upper respiratory tract infection  1  0/74 (0.00%)  2/71 (2.82%) 
Injury, poisoning and procedural complications     
Transfusion reaction  1  10/74 (13.51%)  8/71 (11.27%) 
Procedural pain  1  5/74 (6.76%)  5/71 (7.04%) 
Allergic transfusion reaction  1  2/74 (2.70%)  3/71 (4.23%) 
Fall  1  2/74 (2.70%)  2/71 (2.82%) 
Infusion related reaction  1  3/74 (4.05%)  0/71 (0.00%) 
Laceration  1  1/74 (1.35%)  2/71 (2.82%) 
Skin abrasion  1  2/74 (2.70%)  1/71 (1.41%) 
Lip injury  1  0/74 (0.00%)  2/71 (2.82%) 
Post procedural discharge  1  2/74 (2.70%)  0/71 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  8/74 (10.81%)  14/71 (19.72%) 
Blood bilirubin increased  1  6/74 (8.11%)  8/71 (11.27%) 
White blood cell count decreased  1  9/74 (12.16%)  5/71 (7.04%) 
Aspartate aminotransferase increased  1  5/74 (6.76%)  8/71 (11.27%) 
Platelet count decreased  1  7/74 (9.46%)  4/71 (5.63%) 
Serum ferritin increased  1  6/74 (8.11%)  2/71 (2.82%) 
Weight increased  1  1/74 (1.35%)  5/71 (7.04%) 
Blood creatinine increased  1  3/74 (4.05%)  2/71 (2.82%) 
Blood phosphorus decreased  1  3/74 (4.05%)  2/71 (2.82%) 
Neutrophil count decreased  1  4/74 (5.41%)  1/71 (1.41%) 
Blood magnesium decreased  1  3/74 (4.05%)  1/71 (1.41%) 
Blood alkaline phosphatase increased  1  2/74 (2.70%)  1/71 (1.41%) 
Electrocardiogram QT prolonged  1  1/74 (1.35%)  2/71 (2.82%) 
Lymphocyte count decreased  1  2/74 (2.70%)  1/71 (1.41%) 
Staphylococcus test positive  1  2/74 (2.70%)  1/71 (1.41%) 
C-reactive protein increased  1  0/74 (0.00%)  2/71 (2.82%) 
Platelet count increased  1  2/74 (2.70%)  0/71 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  22/74 (29.73%)  27/71 (38.03%) 
Hypokalaemia  1  20/74 (27.03%)  27/71 (38.03%) 
Hypophosphataemia  1  10/74 (13.51%)  14/71 (19.72%) 
Fluid imbalance  1  12/74 (16.22%)  10/71 (14.08%) 
Hypomagnesaemia  1  8/74 (10.81%)  13/71 (18.31%) 
Hypocalcaemia  1  7/74 (9.46%)  10/71 (14.08%) 
Fluid overload  1  7/74 (9.46%)  5/71 (7.04%) 
Iron overload  1  6/74 (8.11%)  3/71 (4.23%) 
Hypoalbuminaemia  1  6/74 (8.11%)  2/71 (2.82%) 
Hyponatraemia  1  4/74 (5.41%)  4/71 (5.63%) 
Hyperkalaemia  1  4/74 (5.41%)  2/71 (2.82%) 
Hyperferritinaemia  1  2/74 (2.70%)  2/71 (2.82%) 
Hyperuricaemia  1  2/74 (2.70%)  2/71 (2.82%) 
Hypoglycaemia  1  3/74 (4.05%)  1/71 (1.41%) 
Hyperglycaemia  1  1/74 (1.35%)  2/71 (2.82%) 
Fluid retention  1  0/74 (0.00%)  2/71 (2.82%) 
Hypercalcaemia  1  2/74 (2.70%)  0/71 (0.00%) 
Hypoproteinaemia  1  2/74 (2.70%)  0/71 (0.00%) 
Pseudohyperkalaemia  1  2/74 (2.70%)  0/71 (0.00%) 
Rash maculo-papular  1  8/74 (10.81%)  6/71 (8.45%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  4/74 (5.41%)  15/71 (21.13%) 
Pain in extremity  1  8/74 (10.81%)  8/71 (11.27%) 
Musculoskeletal pain  1  4/74 (5.41%)  5/71 (7.04%) 
Arthralgia  1  5/74 (6.76%)  3/71 (4.23%) 
Bone pain  1  2/74 (2.70%)  3/71 (4.23%) 
Pain in jaw  1  1/74 (1.35%)  4/71 (5.63%) 
Myalgia  1  2/74 (2.70%)  2/71 (2.82%) 
Nervous system disorders     
Headache  1  19/74 (25.68%)  20/71 (28.17%) 
Dizziness  1  11/74 (14.86%)  8/71 (11.27%) 
Dysgeusia  1  2/74 (2.70%)  3/71 (4.23%) 
Tremor  1  2/74 (2.70%)  2/71 (2.82%) 
Depressed level of consciousness  1  3/74 (4.05%)  0/71 (0.00%) 
Somnolence  1  1/74 (1.35%)  2/71 (2.82%) 
Psychiatric disorders     
Insomnia  1  16/74 (21.62%)  23/71 (32.39%) 
Anxiety  1  10/74 (13.51%)  7/71 (9.86%) 
Depression  1  1/74 (1.35%)  2/71 (2.82%) 
Confusional state  1  0/74 (0.00%)  2/71 (2.82%) 
Hallucination  1  2/74 (2.70%)  0/71 (0.00%) 
Renal and urinary disorders     
Urinary hesitation  1  5/74 (6.76%)  1/71 (1.41%) 
Dysuria  1  3/74 (4.05%)  2/71 (2.82%) 
Haematuria  1  1/74 (1.35%)  4/71 (5.63%) 
Urinary incontinence  1  2/74 (2.70%)  3/71 (4.23%) 
Acute kidney injury  1  2/74 (2.70%)  2/71 (2.82%) 
Pollakiuria  1  2/74 (2.70%)  1/71 (1.41%) 
Urinary retention  1  2/74 (2.70%)  0/71 (0.00%) 
Reproductive system and breast disorders     
Vaginal haemorrhage  1  2/74 (2.70%)  2/71 (2.82%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  18/74 (24.32%)  14/71 (19.72%) 
Oropharyngeal pain  1  13/74 (17.57%)  13/71 (18.31%) 
Rhinorrhoea  1  9/74 (12.16%)  8/71 (11.27%) 
Dyspnoea  1  5/74 (6.76%)  10/71 (14.08%) 
Productive cough  1  8/74 (10.81%)  4/71 (5.63%) 
Haemoptysis  1  7/74 (9.46%)  2/71 (2.82%) 
Hiccups  1  4/74 (5.41%)  4/71 (5.63%) 
Nasal dryness  1  3/74 (4.05%)  5/71 (7.04%) 
Pleural effusion  1  2/74 (2.70%)  5/71 (7.04%) 
Atelectasis  1  1/74 (1.35%)  5/71 (7.04%) 
Hypoxia  1  4/74 (5.41%)  2/71 (2.82%) 
Pulmonary oedema  1  1/74 (1.35%)  2/71 (2.82%) 
Tachypnoea  1  0/74 (0.00%)  3/71 (4.23%) 
Pulmonary mass  1  2/74 (2.70%)  0/71 (0.00%) 
Wheezing  1  0/74 (0.00%)  2/71 (2.82%) 
Skin and subcutaneous tissue disorders     
Rash  1  22/74 (29.73%)  13/71 (18.31%) 
Petechiae  1  12/74 (16.22%)  10/71 (14.08%) 
Pruritus  1  8/74 (10.81%)  8/71 (11.27%) 
Erythema  1  5/74 (6.76%)  4/71 (5.63%) 
Hyperhidrosis  1  5/74 (6.76%)  2/71 (2.82%) 
Rash generalised  1  4/74 (5.41%)  2/71 (2.82%) 
Skin lesion  1  3/74 (4.05%)  3/71 (4.23%) 
Urticaria  1  4/74 (5.41%)  2/71 (2.82%) 
Alopecia  1  1/74 (1.35%)  4/71 (5.63%) 
Drug eruption  1  2/74 (2.70%)  3/71 (4.23%) 
Blood blister  1  1/74 (1.35%)  3/71 (4.23%) 
Dry skin  1  1/74 (1.35%)  3/71 (4.23%) 
Skin maceration  1  3/74 (4.05%)  1/71 (1.41%) 
Pain of skin  1  1/74 (1.35%)  2/71 (2.82%) 
Pruritus generalised  1  1/74 (1.35%)  2/71 (2.82%) 
Rash papular  1  2/74 (2.70%)  1/71 (1.41%) 
Blister  1  2/74 (2.70%)  0/71 (0.00%) 
Decubitus ulcer  1  2/74 (2.70%)  0/71 (0.00%) 
Pigmentation disorder  1  2/74 (2.70%)  0/71 (0.00%) 
Purpura  1  0/74 (0.00%)  2/71 (2.82%) 
Skin ulcer  1  0/74 (0.00%)  2/71 (2.82%) 
Swelling face  1  2/74 (2.70%)  0/71 (0.00%) 
Vascular disorders     
Hypertension  1  6/74 (8.11%)  8/71 (11.27%) 
Hypotension  1  5/74 (6.76%)  6/71 (8.45%) 
Haematoma  1  2/74 (2.70%)  1/71 (1.41%) 
Deep vein thrombosis  1  0/74 (0.00%)  2/71 (2.82%) 
Haemorrhage  1  2/74 (2.70%)  0/71 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, Sinusitis
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
Results Point of Contact
Name/Title: Clinical Disclosure Office
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01890746     History of Changes
Other Study ID Numbers: 117146
First Submitted: June 27, 2013
First Posted: July 2, 2013
Results First Submitted: March 7, 2016
Results First Posted: June 14, 2016
Last Update Posted: March 27, 2017